ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: 1763

A Phase 3 Randomized Controlled Trial of Anifrolumab in Patients with Moderate to Severe Systemic Lupus Erythematosus

Richard Furie1, Eric Morand 2, Ian Bruce 3, Susan Manzi 4, Kenneth Kalunian 5, Edward Vital 6, Theresa Lawrence-Ford 7, Ramesh Gupta 8, Falk Hiepe 9, Mittermayer Santiago 10, Philip Brohawn 11, Anna Berglind 12 and Raj Tummala 13, 1Zucker School of Medicine at Hofstra/Northwell, New York, NY, 2Monash University, Melbourne, Victoria, Australia, 3University of Manchester, Manchester, United Kingdom, Manchester, England, United Kingdom, 4Allegheny Health Network, Pittsburg, PA, 5Division of Rheumatology, Allergy, and Immunology, University of California San Diego, La Jolla, CA, 6University of Leeds, Leeds, United Kingdom, 7North Georgia Rheumatology, Lawrenceville, GA, 8Baptist Memorial Hospital-Memphis, Memphis, TN, 9Charité University Hospital Berlin, Berlin, Germany, 10Bahiana School of Medicine and Public Health, Bahia, Brazil, 11AstraZeneca, Gaithersburg, MD, 12AstraZeneca, Gothenburg, Sweden, 13AstraZeneca, Gaithersburg, MD, USA, Gaithersburg, MD

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: Disease Activity and Biologics, Safety, Systemic lupus erythematosus (SLE), treatment

  • Tweet
  • Email
  • Print
Session Information

Date: Monday, November 11, 2019

Title: 4M046: Plenary II (1758–1763)

Session Type: Plenary Session II

Session Time: 11:00AM-12:30PM

Background/Purpose: In a phase 2 study in SLE patients (pts), substantial efficacy was observed with anifrolumab, a human monoclonal antibody that binds the type I IFN receptor subunit 1. TULIP-1, a phase 3 randomized, double-blind, placebo-controlled trial (NCT02446912), evaluated efficacy and safety of anifrolumab in pts with moderate to severe SLE.

Methods: SLE pts meeting ACR criteria with SLEDAI-2K ≥6 and BILAG >1 A or >2 B were randomized 2:1:2 to receive IV anifrolumab 300 or 150 mg or placebo (PBO) Q4W and background standard-of-care (SOC) therapy. Stable SOC was required throughout the study except for mandatory attempts at oral corticosteroid (OCS) tapering for pts receiving ≥10 mg/d prednisone or equivalent at entry. The primary endpoint was the difference between Week (W) 52 SRI(4) rates for anifrolumab 300 mg and PBO. Key secondary endpoints included OCS dosage reduction (baseline ≥10 mg/d to ≤7.5 mg/d), W12 CLASI response, and annualized flare rates. BICLA, joint counts, IFN gene signature (IFNGS), and safety were assessed. Post hoc analyses used modified restricted medication rules that were revised after unblinding to be more clinically appropriate.

Results: All 457 randomized pts received ≥1 dose of study drug and were included in the analyses (anifrolumab 300 mg, n=180; anifrolumab 150 mg, n=93; PBO, n=184). Baseline characteristics (Table) and treatment completion rates (~80%) were similar across groups. No difference in W52 SRI(4) response rates was observed for anifrolumab 300 mg (36.2% [65/180]) vs PBO (40.4% [74/184]); SRI(4) rates in the IFNGS test–high subgroup were 35.9% (53/148) and 39.3% (59/151), respectively. In prespecified analyses, any increase in NSAID dose or new NSAID use inadvertently resulted in nonresponse classification. Post hoc analyses, therefore, used modified restricted medication rules. In these post hoc analyses, W52 SRI(4) rates were 46.9% (84/180) for anifrolumab 300 mg vs 43.0% (79/184) for PBO; SRI(4) rates in the IFNGS test–high subgroup were 48.2% (71/148) vs 41.8% (63/151), respectively. Differences favored anifrolumab 300 mg over PBO for BICLA in all pts (46.1% [83/180] vs 29.6% [54 /184], diff: 16.4%; 95% CI: 6.7, 26.2) and in the IFNGS test–high subgroup (45.9% [68/148] vs 27.5% [41/151], diff: 18.4%; 7.7, 29.1). Differences favoring anifrolumab 300 mg vs PBO also occurred for OCS dosage reduction (48.8% [50/103] vs 32.1% [33/102], diff: 16.7%; 95% CI: 3.5, 29.8) and CLASI (43.6% [25/58] vs 24.9% [14/54], diff: 18.7%; 1.4, 36.0) as well as joint activity and flare reduction. IFNGS was suppressed with anifrolumab 300 mg but not PBO. Serologic changes showed trends toward normalization for anifrolumab 300 mg. Serious AEs occurred in 13.9% and 10.8% of pts with anifrolumab 300 and 150 mg vs 16.3% with PBO. Herpes zoster was more common in the anifrolumab groups vs PBO (5.6% and 5.4% vs 1.6%).

Conclusion: Although the primary endpoint, SRI(4), was not achieved in TULIP-1,  numeric improvements achieving thresholds associated with clinical benefit were observed for BICLA, OCS, and other organ-specific endpoints. Anifrolumab 300 mg suppressed IFNGS and was generally well tolerated.

Writing assistance by Ellen Stoltzfus, PhD (Fishawack).

Table. Baseline Demographics and Disease Characteristics


Disclosure: R. Furie, AstraZeneca/MedImmune, 2, 5, AstraZeneca/Medimmune, 2, 3; E. Morand, AstraZeneca, 2, 5, 8, Bristol Myers Squibb, 2, Eli Lilly, 5, Janssen, 2, 5, Merck Serono, 2, 5, UCB, 2; I. Bruce, Astra Zenica, 5, AstraZeneca, 5, Eli Lilly, 5, 8, Genzyme Sanofi, 2, GlaxoSmithKline, 2, 5, 8, GSK, 2, 5, 8, ILTOO, 5, Iltoo, 5, MedImmune, 5, 8, Medimmune, 5, Merck Serono, 5, 8, Merk Serono, 5, Roche, 5, 8, Sanofi Genzyme, 2, UCB, 2, 5, 8, UCB Pharma, 5, 8; S. Manzi, Allegheny Health Network, 3, AstraZeneca, 2, 5; K. Kalunian, AbbVie, 9, Abbvie, 5, Amgen, 5, AstraZeneca, 5, Biogen, 5, 9, BMS, 2, 9, Chemocentryx, 5, Eli Lilly, 5, 9, Equillium, 5, Exagen, 2, Genentech/Roche, 5, Gilead, 9, Gilead Sciences, Inc., 9, GSK, 5, Idosia, 2, Janssen, 5, Kirin, 2, MedImmune, 5, Nektar, 5, Pfizer, 2, Resolve, 2, Roche, 9, Takeda, 2, UCB, 2; E. Vital, AstraZeneca, 3; T. Lawrence-Ford, Amgen, 5, 8, Abbvie, 5, 8, Lilly, 5, 8, Novartis, 5, 8, Sanofi Genzyme/Regeneron, 5, 8, Flexion, 5, 8, Horizon, 5, 8, Janssen, 5, 8, GSK, 5, 8, Mallinckrodt, 5, 8, Pfizer, 5, 8, UCB, 5, 8, Gilead, 5, 8, Incyte; R. Gupta, None; F. Hiepe, None; M. Santiago, None; P. Brohawn, AstraZeneca, 1, 2, 3, 4; A. Berglind, AstraZeneca, 3; R. Tummala, AstraZeneca, 3.

To cite this abstract in AMA style:

Furie R, Morand E, Bruce I, Manzi S, Kalunian K, Vital E, Lawrence-Ford T, Gupta R, Hiepe F, Santiago M, Brohawn P, Berglind A, Tummala R. A Phase 3 Randomized Controlled Trial of Anifrolumab in Patients with Moderate to Severe Systemic Lupus Erythematosus [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/a-phase-3-randomized-controlled-trial-of-anifrolumab-in-patients-with-moderate-to-severe-systemic-lupus-erythematosus/. Accessed .
  • Tweet
  • Email
  • Print

« Back to 2019 ACR/ARP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-phase-3-randomized-controlled-trial-of-anifrolumab-in-patients-with-moderate-to-severe-systemic-lupus-erythematosus/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology